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• W3205270945 abstract "Patients with metastatic non-small cell lung cancer (mNSCLC) without actionable driver mutation(s) who have progressed after cytotoxic chemotherapy plus immune checkpoint inhibitors (ICI) have limited treatment options and represent an unmet need. The safety and efficacy of TIL cell therapy for mNSCLC patients who failed to respond or progressed on nivolumab has been evaluated in a Phase 1 clinical trial (Creelan B, AACR 2020), demonstrating an objective response rate (ORR) of 25% including 17% durable CRs. Of note, responders in this study had PD-L1 tumor proportion score (TPS) expression levels of 0-10%. As patients with negative or low PD-L1 expression levels are in need of therapeutic options and TIL therapy appears to offer such a therapeutic potential, we initiated the IOV-LUN-202 study, evaluating Iovance TIL cell therapy with LN-145 in patients with mNSCLC without actionable driver mutation(s), who have progressed on or following a single line of approved systemic therapy consisting of combined ICI + chemotherapy ± bevacizumab. IOV-LUN-202 (NCT04614103) is an actively enrolling, open-label, multi-cohort, non-randomized, multicenter Phase 2 study. Patient cohorts (n=40 ea.) based on TPS at metastatic diagnosis prior to ICI use are Cohort 1 (TPS <1%) and Cohort 2 (TPS ≥ 1%). Cohort 3 (TPS <1%; n=15), utilizes core biopsies for tumor acquisition for patients unable to undergo a surgical harvest with a 16-day Gen 3 manufacturing process. LN-145 is generated at centralized GMP facilities and the final cryopreserved infusion product is shipped to the sites. All patients receive TIL therapy consisting of nonmyeloablative lymphodepletion with cyclophosphamide (60 mg/kg x 2) + fludarabine (25 mg/m2 x 5), followed by a single infusion of autologous LN-145 (Day 0) and up to 6 doses of IL-2 (600,000 IU/kg). Key eligibility includes: ≥ 18 yr of age; 1 prior line of therapy; ≥ 1 lesion(s) available for TIL generation and a remaining RECIST-measurable lesion; and ECOG PS of 0-1. For each cohort, the primary endpoint is ORR per RECIST v1.1. Secondary endpoints are safety, CR rate, DOR, DCR, PFS, and OS.Table 1IOV-LUN-202 Patient CohortsCOHORTPATIENT POPULATIONMetastatic NSCLC without an actionable driver mutation and progressive disease on or following a single line of approved systemic therapy including ICI + Chemo ± BevacizumabSAMPLE SIZE1PD-L1 TPS < 1%N = 402PD-L1 TPS ≥ 1%N = 403PD-L1 TPS < 1% / Core BiopsiesN = 154RetreatmentN = undefined Open table in a new tab ▪▪▪ ▪▪▪" @default.
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• W3205270945 date "2021-10-01" @default.
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• W3205270945 title "P14.04 A Phase 2 Multicenter Study of Iovance Autologous Tumor Infiltrating Lymphocytes (TIL, LN-145) Cell Therapy in Patients With Metastatic NSCLC" @default.
• W3205270945 doi "https://doi.org/10.1016/j.jtho.2021.08.334" @default.
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